LDFWART With Docetaxel in Patients With Platinum-Resistant Recurrent Ovarian Carcinoma

NCT ID: NCT02083536

Last Updated: 2016-08-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31

Brief Summary

The ultimate clinical aim of this proposed phase I trial is to evaluate the toxicity and determine the recommended phase II dose of combining the effect of LDFWART following administration of docetaxel for 6 cycles in patients with recurrent platinum-resistant ovarian cancer.

Conditions

Ovarian Cancer; Ovarian Carcinoma; Recurrent Ovarian Cancer; Recurrent Ovarian Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LDFWART + Docetaxel

This study has 6 treatment cycles given at 3 weeks intervals ± 3 days. A cycle is defined as 1 treatment of morning Docetaxel and afternoon Low Dose Fractionated Whole Abdominal Radiation Therapy (LDFWART). The first day of the first treatment is designated "study day 1".

Group Type: EXPERIMENTAL

Low Dose Fractionated Whole Abdominal Radiation Therapy

Intervention Type: RADIATION

A single fraction of LDFWART will be given 6-8 hours after the start of morning administration of Docetaxel for 6 cycles (the time of the start Docetaxel will be counted as the frame of reference for when the LDFWART can be given).

Docetaxel

Intervention Type: DRUG

Chemotherapy will consist of 6 cycles of Docetaxel. Each cycle will follow standard of care and will be scheduled every 3 weeks ± 3 days. Chemotherapy should be administered in the morning to allow 6-8 hours before Radiation Therapy. On Day 1 of each cycle, chemotherapy will consist of Docetaxel 60 mg/m² infused intravenously over 30-60 minutes (with premedication of dexamethasone 10 mg given IV 30-60 minutes prior to docetaxel administration).

Interventions

Low Dose Fractionated Whole Abdominal Radiation Therapy

A single fraction of LDFWART will be given 6-8 hours after the start of morning administration of Docetaxel for 6 cycles (the time of the start Docetaxel will be counted as the frame of reference for when the LDFWART can be given).

Intervention Type: RADIATION

Docetaxel

Chemotherapy will consist of 6 cycles of Docetaxel. Each cycle will follow standard of care and will be scheduled every 3 weeks ± 3 days. Chemotherapy should be administered in the morning to allow 6-8 hours before Radiation Therapy. On Day 1 of each cycle, chemotherapy will consist of Docetaxel 60 mg/m² infused intravenously over 30-60 minutes (with premedication of dexamethasone 10 mg given IV 30-60 minutes prior to docetaxel administration).

Intervention Type: DRUG

Other Intervention Names

LDFWART; Taxotere

Eligibility Criteria

Inclusion Criteria

• 1. Patients must have platinum-resistant disease relapsing within 6 months or less from the date of their last cycle of initial adjuvant chemotherapy recurrent adenocarcinoma from a primary ovarian, tubal, or peritoneal cancer following first-line chemotherapy for metastatic disease. There is no limit on prior number of chemotherapy regimens. Patients who have received prior systemic docetaxel and platinum-based chemotherapy are eligible
• 1.1 Patients must have ≥ 1cm measurable disease on imaging studies independent of patients having an optional surgical salvage procedure.
• 2. Patients must have a life expectancy of at least 6 months.
• 3. Patients must have Karnofsky performance status of ≥ 60 or Gynecology Oncology (GOG) performance status of ≤ 2 (see www.GOG.org website).
• 4. Age 18 - 80 years old
• 5. Patients must have an adequate bone marrow, renal, and hepatic function:

• 5.1 WBC: ≥ 3,000 /mcl
• 5.2 ANC: ≥ 1,500 /mcl
• 5.3 Platelets: ≥ 100,000 /mcl
• 5.4 Creatinine: < 2.0 mg/dcl
• 5.5 Bilirubin: < 1.5x institutional normal value
• 5.6 LDH, GGT, SGPT (ALT), SGOT (AST), and ALK Phos:< 3x institutional normal value.
• 6. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

• 1. Patients who have received prior radiotherapy to the chest, whole abdomen, or lower extremities above the knees.
• 2. Patients who have received prior radiation therapy to the head, neck, or lower extremities below the knees if greater than 3 years prior to study entry.
• 3. Evidence of extra-abdominal extension of disease (such as groin nodes, lung, supraclavicular nodes, and pleural fluid).
• 4. Patients may not be receiving any other investigational agents within 4 weeks preceding the start of study treatment) or chemotherapy for at least 3 weeks preceding the start of study treatment.
• 5. Patients who have been diagnosed with another prior malignant tumor within 3 years of study entry, excluding non-melanoma skin cancer and carcinoma in situ of the cervix.
• 6. Patients with prior history of a severe hypersensitivity reaction to paclitaxel (polysorbate 80-Cremophor).
• 7. Patients with current history of uncontrolled hypertension, angina pectoris, heart failure, cardiac dysrhythmias, pericardial disease, cardiomyopathy, or active infection.
• 8. Presence of any medical condition that in the opinion of the investigator deems the patient unable to participate.
• 9. Females of child-bearing potential. It is expected that ovarian cancer patients would have had a hysterectomy and/or oophorectomy as part of the original standard of care.
• 10. Patients that are < 18 yrs. of age or > 80 yrs. of age.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Aaron Wolfson

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aaron H Wolfson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Other Identifiers

20110671

Identifier Type: -

Identifier Source: org_study_id